The Unifill EZMix can hold two or more primary drug containers within a single glass barrel, and can store a combination of liquid stable or lyophilized drugs along with up to 1mL of diluent for reconstitution.
However, unlike other dual or multi-chamber devices which have gone before it – such Pfizer’s device for its hemophilia treatment Xyntha, or Vetter’s Lyo-Ject device – the EZMix’s safety apparatus is inside the glass barrel.
Stephen Allan, Unilife’s VP, Marketing & Communications, told in-PharmaTechnologist: “There are dual chamber pre filled syringes on the market at the moment.
“But the Unifill EZMix multiple-chamber ready-to-fill (prefilled) syringes are the first dual chamber or multi chamber with an integrated safety mechanism.
“This is important, because in the US and Europe at the moment, it is a requirement for health care practice to protect workers from the needle stick injury.”
Planting the flag
The inclusion of a safety appliance within the vial for multi-chamber delivery was previously thought impossible, because the plastic needed to create the device can interact with the lyophilized drugs.
Now the Pennsylvania-based drugs manufacturer hopes its product’s uniqueness will add substantial value to their pre-filled syringes business.
Allan added: “Before we developed the technology the market thought it was impossible to achieve an integrated safety system.
“The fact that we have overcome this issue is unique; it’s the world’s first and only device that fulfills this need.
“Other multi-chamber syringes all use ancillary devices that clip on which causes problems for the patient, the heath care worker and the manufacturer.
“It can slow down fill and finish capabilities, distributing the drug to the patient isn’t as easy, and it can also be a problem to those who are needle phobic because it’s 60 to 70 per cent larger than a standard pre-filled syringe.
“We are now extending our platform of pre filled syringes to accommodate all pre-filled syringes. This will add significant value to our activities in this sector.”
Unilife also anticipates added value because the device follows a growing market trend for lyophilized drugs – which make up a third of all US FDA approved drugs over the past three years.
Unilife CEO Alan Shortall said: “With the development pipelines of many pharmaceutical companies teeming with complex biologics that must be reconstituted at the point of delivery, we expect the market for lyophilized drugs and vaccines to experience double-digit growth for the foreseeable future.
“In addition, there are dozens of approved drugs requiring reconstitution that are approaching patent expiration and coming under increased pressure from brand-name, biosimilar or generic competition.”